Week In Review, September 1, 2011

The PharmaCertify™ Team

We’re a little bit early this week, but with good reason. We’ve got to head to the grocery store, and the sporting goods store and get the portable grill and folding table all cleaned up to get ready for Saturday – the start of the collegiate football season!! Finally, the day has arrived! Noon to midnight football on network and sports channels galore! Have we died and gone to heaven? We think so. (Okay some of us think so. Check that…the person writing this thinks so, and he who writes the review, speaks for the group.) However, before we (I) get busy with the tasks at hand, there is the important business of this week’s edition of the PC News Week in Review. Fire up the band, get on your feet and cheer, ‘cause it’s game time!

Let’s kick this off with a story that has a football twist. Well, actually it’s a football story with a compliance twist. After his recent activation from the physically unable to play list, Peyton Manning made the following comment about his recovery from neck surgery, “I don’t know what HIPAA stands for, but I believe in it and I practice it.”  Well, Peyton, we’re pretty sure HIPAA doesn’t preclude you from sharing information about your condition, but props for referencing the law. (By the way, it stands for Health Insurance Portability and Accountability Act.) We hope that the change in Peyton’s playing status means he’ll be back in DSRL action soon as well!

An article in the Canadian Medical Association Journal is calling for Health Canada to take a page from the United States playbook. The article is calling for public disclosure of clinical trial results to the public. There are laws that prohibit Health Canada from releasing companies’ trade secrets, so the clinical trial results, which could be valuable to physicians and the public, are not known.

Down…set…has there been a hike in the dollars spent by the industry on doctors? According to an analysis by the Financial Times and a pharmaceutical industry data provider, it looks like that might be the case. The analysis shows that nearly $150M has been spent on physicians so far this year. The majority of the data is from the first quarter, and represents a potential increase in spending over last year. We’ll let the clock run down on this one before making a call as to whether spending is really on the rise.

The co-founders of the Digital Healthcare Coalition are adding their voices to the crowd calling for the FDA to issue guidance on the use of social media. In an interview with CNET, the two founders said the FDA not only needs to issue guidance on the matter, but also that guidance should be specific. Vagueness will not work in the world of social media and the lack of certainty from the FDA is causing too much inaction. According to the Digital Healthcare Coalition, nearly 90 percent of the industry is not willing to experiment in social media.

According to MedAd News, industry insiders are saying the penalty flag that was dropped against Bayer over tweets on its UK and Ireland pages does not necessarily signal that the industry should be out of the social media game. While the regulations in the US present their own challenge, the situation with Bayer points more to the cultural differences between the UK and the US regarding drug advertising and the regulatory differences between the two countries.

It’s a turnover for CardioNet. The cardiac monitoring company was asked to turnover documents dating back five years in relation to a false claims act investigation by the DOJ. The company said it could not predict the course of the investigation, which stems from claims that the company used inappropriate diagnosis codes when submitting Medicare claims for its monitoring services. The company’s fans reacted with boos and a stock sell off of over 20% on the day the investigation was announced.

That’s it for this week’s PC News Week in Review. Remember, if you’re looking to complete your company’s commercial compliance game plan with up-to-date training on topics ranging from the Anti-kickback statute to state and federal physician spend disclosure laws and everything in between, hustle over to www.pharmacertify.com to see a demo of our modules.

Whether or not your weekend plans involve tailgating and cheering along with 100,000 of your closest friends, either in person or on television, we hope you have a great long holiday weekend. Be safe and go team!

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